Home NDC 70000-0701 Childrens Allergy Relief
Product NDC 70000-0701
11-digit product format 700000701
Labeler code 70000
Product ID 70000-0701_75d2b34d-b2db-45e0-8e14-e951bba04c13
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 110, LLC. DBA Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-19
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Allergy Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049906 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0701-1 Childrens Allergy Relief 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 3 70000-0701-1 Childrens Allergy Relief 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0701 CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] 2 Current NDC, 2 package rows 20250429_d2dab450-cf82-4be2-a4e2-630295fb59ab.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 99 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70000-0701-1 70000070101 1 BOTTLE, PLASTIC in 1 CARTON (70000-0701-1) / 118 mL in 1 BOTTLE, PLASTIC 2024-12-19 No No Current